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This clinical trial involves collecting peripheral blood, ulcer tissue, and fecal samples from diabetic ulcer patients for bioinformatics analysis to screen genetic markers significantly associated with ulcer risk and healing differences. Furthermore, multi-omics data will be integrated to establish a diabetic ulcer risk prediction model. Based on key single nucleotide polymorphisms and their regulatory pathways, potential new drug targets for promoting healing will be explored, providing a genetic basis for personalized treatment.
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| Measure | Description | Time Frame |
|---|---|---|
| Ulcer Healing Time | Three years |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Ulcer Area | Absolute change in ulcer area over three years in cm2 | Three years |
| Number of Amputation Events | Three years |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of diabetic ulcer patients who visit the The First Affiliated Hospital of University of South China during the trial period and meet the inclusion/exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiecan Zhou, Prof. | Contact | +86-734-8279018 | zhoujiecan@fsyy.usc.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of South China | Recruiting | Hengyang | Hunan | 421001 | China |
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Peripheral blood, ulcer tissue, and fecal samples from diabetic ulcer patients will be collected and detected.
| Ulcer Recurrence | Number of diabetic foot ulcers with recurrence at three years | Three years |
| Time to Complete Wound Closure | Time to 100% wound closure utilizing Cox proportional hazards model, a statistical measure of difference of time to event (healing). The analysis will consider covariates that might influence the outcome in the trial. | Three years or wound closure |
| Number of Foot Infections | Three years |
| Quality of Life Assessment | The Cardiff Wound Impact Schedule questionnaire to measure quality of life. Measure of well-being items from each scale are summated, physical symptoms, everyday living and social life. The items are rated for the extent of the experience and each item is given a number value. This allows the patients to weight the items included in the scale. The well-being scale is scored on a 5-point Likert scale, with response options from 'strongly agree' to 'strongly disagree'. All three scales are then transformed onto a minimum = 0 up to a maximum = 100, where a low score indicates worse, and a high score indicates better feeling of well-being. | Three years |
| Length of Stay | Three years |